Mucositis refers to inflammation of the mucous membranes caused by an infection. In the respiratory tract, mucositis affects not only the nose, sinuses and the large airways but also the small airways of the lungs. Mucositis of the nose and sinuses is called chronic rhinosinusitis. In the smaller airways it is termed asthma.
Asthma is a common disorder causing marked morbidity and significant mortality. The incidence of asthma in the United States and other Western countries is over 5% and growing. In the US alone asthma affects approximately 17 million people and accounts for nearly half a million hospital admissions each year.
In general the cause of chronic mucositis in the respiratory tract is not known. However, in a percentage of patients, superficial or non-invasive fungal organisms appear to be present within the mucus. It appears that respiratory tract mucositis is caused, at least in part, by a chronic fungal infection.
Typically, mucositis may be treated with surgery, steroid therapy or anti-inflammatory agents. However such therapies fail to address the infection components of the mucositis.
Alternatively treatment may include mucosal administration of an anti-fungal agent. U.S. Pat. No. 6,291,500 (Ponikau) describes the treatment of non-invasive fungus-induced mucositis by mucosal administration of a formulation including an anti-fungal agent. According to Ponikau, the formulation may also include an antibiotic.
The Applicant has noted that although such mucosal administration can reduce symptoms of mucositis, suppress severity or reduce relapses of the condition if administered for a long period of time, this type of therapy of an anti-fungal agent administered superficially to the mucosa suffers from the disadvantage that it does not address the invasive component of the fungal infection. Indeed mucosal administration has the potential to lead to the development of resistant fungi where only a small amount of the anti-fungal agent reaches the fungi inhabiting the deeper layers of mucosal membranes allowing them to multiply at low levels of anti-fungal exposure, thereby exacerbating the underlying problem.
WO 02/07682 (Vyden) describes the treatment of atopic disorders, including asthma, using an anti-fungal agent and an antibiotic, wherein the treatment also requires the reduction or cessation of use of emollients by the patient.
The Applicant has surprisingly found, however, that such reduction or cessation of emollient use is in fact often unnecessary, and effective treatment of asthma and other respiratory tract mucositis can be achieved using at least one anti-fungal agent and at least one anti-bacterial agent without need for a reduction or cessation of use of emollients.
It is an object of the present invention to provide an effective treatment for respiratory tract mucositis which overcomes or at least substantially ameliorates the shortcomings of the prior art.